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Study Comparing Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Clavicle Fractures

This study has been withdrawn prior to enrollment.
(duplicate study)
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01311219
First received: March 1, 2011
Last updated: March 7, 2011
Last verified: March 2011

March 1, 2011
March 7, 2011
May 2009
May 2011   (final data collection date for primary outcome measure)
Disability of the Arm, Shoulder, and Hand (DASH) [ Time Frame: 2, 6, and 12 weeks and 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01311219 on ClinicalTrials.gov Archive Site
The Constant Pain Score [ Time Frame: 2, 6, and 12 weeks and 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Comparing Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Clavicle Fractures
Comparison of Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Acute, Displaced, Midshaft Clavicle Fractures: a Prospective Randomized Trial

Patients with acute, displaced fratures of the middle third of the clavicle will be randomly assigned into either the non-operative treatment group or the operative treatment group. The operative treatment group will be randomly assigned to repair with either an intramedullary device or a plate and screws. Pre-operative variables will be accounted for in detail. Operative variables including duration of surgery, length of incision, fluoroscopy times, blood loss, and quality of reduction will be recorded. Patients will be followed with regular post-operative visits in which radiographs and clinical examination will be performed. Outcome variables will include post-operative pain, time to union, union/non-union rate, return to work, return to activity, radiographic outcome, complication rates, incidence of repeat procedures, cosmesis, and functional outcome based on strength, range of motion, and scoring systems. There are five hypotheses for this study: 1) Operative treatment of acute displaced midshaft clavicle fractures will yield better patient-based functional outcomes when compared to nonoperative treatment as measured by physical assessment of strength and range of motion, standardized scoring systems and return to normal daily activities. 2) Operative treatment of acute displaced midshaft clavicle fractures will yield lower radiographically-determined nonunion rates, improved cosmesis and fewer complaints of residual pain when compared to nonoperative treatment. 3) Operative treatment of acute displaced midshaft clavicle fractures with intramedullary pinning will be more efficacious than operative treatment with plate fixation as measured by duration of surgery, length of incision, fluoroscopy time, blood loss, and quality of reduction. 4) Operative treatment of acute displaced midshaft clavicle fractures with intramedullary pinning will result in fewer complications than operative treatment with plate fixation including; nonunion rate, infection, incidence of repeat procedures, refracture rate, and hardware malfunction. 5) Operative treatment of acute displaced midshaft clavicle fractures with intramedullary pinning will yield lower radiographically-determined nonunion rates, improved cosmesis, and fewer complaints of residual pain when compared to operative treatment with plate fixation.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fracture of Clavicle
  • Other: Non-operative Treatment
    A figure-of-8 brace will be applied to afflicted extremity in clinic. The patient will be instructed on proper application of the brace and asked to continue wearing the brace for 2 to 6 weeks, depending on the patient's level of comfort.
  • Procedure: Operative Treatment-Plate Fixation
    Plate fixation of the clavicle fracture will be performed utilizing a 3.5-mm dynamic compression plate.
  • Procedure: Operative Treatment-Intramedullary Pinning
    Clavicle fracture will be repaired through intramedullary pinning using The Rockwood Clavicle Pin (DePuy Orthopaedics, Warsaw, IN).
  • Active Comparator: 1
    Non-operative Treatment
    Intervention: Other: Non-operative Treatment
  • Active Comparator: 2
    Operative Treatment-Plate fixation
    Intervention: Procedure: Operative Treatment-Plate Fixation
  • Active Comparator: 3
    Operative Treatment-Intramedullary Pinning
    Intervention: Procedure: Operative Treatment-Intramedullary Pinning

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
480
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria: All candidates with a radiographically confirmed, displaced, midshaft clavicle fracture, between the ages of 16 and 80.

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Exclusion Criteria: Patients presenting with ipsilateral shoulder girdle injury, open fracture, pathologic fracture, or associated neurologic injury. Patients who are pregnant and therefore, unable to undergo radiologic assessment. Patients deemed incompetent to make medical decisions regarding their own health care. Patients unwilling or unable to complete postoperative evaluation at 2, 6, and 12 weeks and long term follow-up evaluation at 6 and 12 months. Prisoners who will be difficult to complete follow-up.

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Both
16 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01311219
1109438-1
No
Richard A. White, M.D., University of Missouri-Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Richard A White, M.D. University of Missouri-Columbia
University of Missouri-Columbia
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP